Phase II Dose Finding Study of RDEA3170 Versus Placebo in Japanese Patients With Gout or Asymptomatic Hyperuricemia

Launched by ASTRAZENECA · Mar 4, 2014

Keywords

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Eligibility criteria

• Inclusion Criteria:
• * Subject meets any of the following criteria and with sUA ≤10.0 mg/dL:
• • 1. sUA level of \>7.0 mg/dL at 7 days prior to baseline with gout;
• • 2. sUA level of ≥8.0 mg/dL at 7 days prior to baseline without gout but with complications (hypertension, ischemic heart disease, diabetes, metabolic syndrome);
• • 3. sUA level of ≥9.0 mg/dL at 7 days prior to baseline without gout and complications.
• Exclusion Criteria:
• • Subject with an acute gout flare that has not resolved at least 14 days prior to the baseline visit.
• • Subject has a history or suspicion of kidney stones.
• • Subject has an estimated creatinine clearance \<60 mL/min calculated by the Cockcroft Gault formula
• • Subject is receiving strong or moderate CYP3A inhibitors